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Multiple Dose Study of PF-04991532 in Patients With Type 2 Diabetes

Last updated on November 8, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Chula Vista, California, 91911 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes Mellitus, Type 2 Diabetes Mellitus, Glucose Metabolism Disorders
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with type 2 diabetes mellitus who are taking metformin only. Treatment
should be stable, where this is defined as no change in the treatment, including
dose, over the past 2 months. Subjects treated with a sulfonylurea (SU) or a
dipeptidyl peptidase-4 inhibitor (DPP-4i) in combination with metformin may be
eligible if washed off the SU or DPP-4i to metformin only for a minimum of 4 weeks
before dosing. Subjects being switched over from an SU and metformin or a DPP-4i and
metformin to metformin only will still need to meet the fasting glucose requirements
on Day -2 as defined in the protocol.

- Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight >50 kg (110
lbs).

- Fasting C-peptide >0.8 ng/mL.

- HbA1c >/=7% and >/=10%. If the patient requires to be washed off an SU or DPP-4i, the
HbA1c limits will be >/=6.5% and =9%.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease. Subjects who have chronic conditions other than T2DM (for example,
hypercholesterolemia or hypertension) but are controlled by either diet or stable
(for the last 2 months) doses of medications may be included as well.

- Evidence or history of diabetic complications with significant end-organ damage.

- Any condition possibly affecting drug absorption (eg, gastrectomy).

- History of stroke, transient ischemic attack, or myocardial infarction within the
past 6 months.

- History of coronary artery bypass graft or stent implantation.

- Clinically significant peripheral vascular disease.

- Any history or clinical evidence of congestive heart failure, NYHA Classes II-IV.

- Current history of angina/unstable angina.

- ECG findings suggestive of asymptomatic myocardial ischemia or QTc >470 msec at
screening.

- One or more self-reported episodes of hypoglycemia within the last 3 months, or two
or more self-reported episodes of hypoglycemia within the last 6 months.

- Screening or Day -2 fasting (>/=8 hours) glucose, =90 or >/=270 mg/dL, confirmed by
a single repeat if deemed necessary.

- A positive urine drug screen.

- Use of tobacco or nicotine-containing products in excess of the equivalent of 10
cigarettes per day.

- History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of
beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.

- Certain concomitant medications are excluded, as defined in the protocol.

- Screening supine blood pressure >/=160 mm Hg (systolic) or >/=100 mm Hg (diastolic).

- Certain laboratory values (for example, triglyceride and liver function test
results).

- Pregnant or nursing females; females of childbearing potential.

NCT01129258
Pfizer
Completed
Multiple Dose Study of PF-04991532 in Patients With Type 2 Diabetes

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Descriptive Information
Brief Title  ICMJE Multiple Dose Study of PF-04991532 in Patients With Type 2 Diabetes
Official Title  ICMJE A Phase 1 Placebo-Controlled Trial to Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Escalating Oral Doses of PF-04991532 in Adult Patients With Type 2 Diabetes Mellitus (T2DM)
Brief SummaryThe purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-04991532 following multiple (14 days) escalating oral doses in patient wtih type 2 diabetes.
Detailed DescriptionSafety/Tolerability, PK, and PD
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Glucose Metabolism Disorders
Intervention  ICMJE
  • Drug: PF-04991532
    Subjects will be dosed wtih PF-04991532 for 14 days. The tentative dosing schedule is 30, 100, 300, 1000, and 1500 mg QD, and 150 and 500 mg BID). Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses. All doses will be administered as tablets (10, 50, and 150 mg strengths). In each cohort 9 subjects will receive PF-04991532 and 3 will receive placebo.
  • Drug: Placebo
    Placebo to match PF-04991532 will be provided. Subjects will be dosed for 14 days. In each cohort 9 subjects will receive PF-04991532 and 3 will receive placebo.
Study Arms  ICMJE
  • Experimental: PF-04991532
    Intervention: Drug: PF-04991532
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2011)
110
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2010)
84
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion DateDecember 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus who are taking metformin only. Treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 2 months. Subjects treated with a sulfonylurea (SU) or a dipeptidyl peptidase-4 inhibitor (DPP-4i) in combination with metformin may be eligible if washed off the SU or DPP-4i to metformin only for a minimum of 4 weeks before dosing. Subjects being switched over from an SU and metformin or a DPP-4i and metformin to metformin only will still need to meet the fasting glucose requirements on Day -2 as defined in the protocol.
  • Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight >50 kg (110 lbs).
  • Fasting C-peptide >0.8 ng/mL.
  • HbA1c >/=7% and >/=10%. If the patient requires to be washed off an SU or DPP-4i, the HbA1c limits will be >/=6.5% and

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. Subjects who have chronic conditions other than T2DM (for example, hypercholesterolemia or hypertension) but are controlled by either diet or stable (for the last 2 months) doses of medications may be included as well.
  • Evidence or history of diabetic complications with significant end-organ damage.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • History of stroke, transient ischemic attack, or myocardial infarction within the past 6 months.
  • History of coronary artery bypass graft or stent implantation.
  • Clinically significant peripheral vascular disease.
  • Any history or clinical evidence of congestive heart failure, NYHA Classes II-IV.
  • Current history of angina/unstable angina.
  • ECG findings suggestive of asymptomatic myocardial ischemia or QTc >470 msec at screening.
  • One or more self-reported episodes of hypoglycemia within the last 3 months, or two or more self-reported episodes of hypoglycemia within the last 6 months.
  • Screening or Day -2 fasting (>/=8 hours) glucose, /=270 mg/dL, confirmed by a single repeat if deemed necessary.
  • A positive urine drug screen.
  • Use of tobacco or nicotine-containing products in excess of the equivalent of 10 cigarettes per day.
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
  • Certain concomitant medications are excluded, as defined in the protocol.
  • Screening supine blood pressure >/=160 mm Hg (systolic) or >/=100 mm Hg (diastolic).
  • Certain laboratory values (for example, triglyceride and liver function test results).
  • Pregnant or nursing females; females of childbearing potential.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01129258
Other Study ID Numbers  ICMJE B2611004
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now